Summary Background Mammography is the only proven method for breast cancer screening that reduces mortality, although it is inaccurate in young women or women with dense breasts. We investigated the ...efficacy of adjunctive ultrasonography. Methods Between July, 2007, and March, 2011, we enrolled asymptomatic women aged 40–49 years at 42 study sites in 23 prefectures into the Japan Strategic Anti-cancer Randomized Trial (J-START). Eligible women had no history of any cancer in the previous 5 years and were expected to live for more than 5 years. Randomisation was done centrally by the Japan Clinical Research Support Unit. Participants were randomly assigned in 1:1 ratio to undergo mammography and ultrasonography (intervention group) or mammography alone (control group) twice in 2 years. The primary outcome was sensitivity, specificity, cancer detection rate, and stage distribution at the first round of screening. Analysis was by intention to treat. This study is registered, number UMIN000000757. Findings Of 72 998 women enrolled, 36 859 were assigned to the intervention group and 36 139 to the control group. Sensitivity was significantly higher in the intervention group than in the control group (91·1%, 95% CI 87·2–95·0 vs 77·0%, 70·3–83·7; p=0·0004), whereas specificity was significantly lower (87·7%, 87·3–88·0 vs 91·4%, 91·1–91·7; p<0·0001). More cancers were detected in the intervention group than in the control group (184 0·50% vs 117 0·32%, p=0·0003) and were more frequently stage 0 and I (144 71·3% vs 79 52·0%, p=0·0194). 18 (0·05%) interval cancers were detected in the intervention group compared with 35 (0·10%) in the control group (p=0·034). Interpretation Adjunctive ultrasonography increases sensitivity and detection rate of early cancers. Funding Ministry of Health, Labour and Welfare of Japan.
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GEOZS, IJS, IMTLJ, KILJ, KISLJ, NUK, OILJ, PNG, SAZU, SBCE, SBJE, UL, UM, UPCLJ, UPUK, ZRSKP
Abstract Context End-of-life discussions are crucial for providing appropriate care to patients with advanced cancer at the end of their lives. Objectives To explore associations between end-of-life ...discussions and bereaved families’ depression and complicated grief, as well as the quality of patient death and end-of-life care . Methods A nationwide questionnaire survey of bereaved family members was conducted between May and July 2014. A total of 13,711 bereaved family members of cancer patients who were cared for by specialist palliative care services at 75 institutions throughout Japan and died before January 2014 participated. We evaluated the prevalence of depression (defined as the Patient Health Questionnaire-9 ≥10) and complicated grief (defined as the Brief Grief Questionnaire ≥8) in bereaved family members. Moreover, we evaluated the quality of death and end-of-life care withthe Good Death Inventory (GDI) and the Care Evaluation Scale (CES), respectively. Results A total of 9123 questionnaires were returned (response rate 67%), and 80.6% of the respondents reported that they had end-of-life discussions. After propensity-score weighted adjustment, the results showed that bereaved family members who had end-of-life discussions had a lower frequently of depression (17.3% vs. 21.6%; P < 0.001) and complicated grief (13.7% vs. 15.9%; P = 0.03). End-of-life discussions were associated with better quality of death (The GDI score, 47.2 ± 8.5 vs. 46.1 ± 9.4; P < 0.001) and end-of-life care (the CES score, 84.1 ± 11.4 vs. 78.9 ± 14.3; P < 0.001). Conclusions End-of-life discussions may contribute to reducing depression and complicated grief in bereaved family members, and enable patients to experience quality end-of-life care and a good death.
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GEOZS, IJS, IMTLJ, KILJ, KISLJ, NLZOH, NUK, OILJ, PNG, SAZU, SBCE, SBJE, UILJ, UL, UM, UPCLJ, UPUK, ZAGLJ, ZRSKP
Background:The effect of treatment with paclitaxel-containing devices (PTXD) on mortality in patients with peripheral artery disease remains controversial.Methods and Results:An independent ...patient-level meta-analysis of 12 clinical trials (1,389 PTXD patients and 1,192 non-PTXD patients) was conducted. This study included 7 pivotal trials and 5 post-marketing surveillance studies on endovascular treatment for femoropopliteal artery by 6 companies. The primary endpoint was all-cause death, and 5-year cumulative mortality was estimated by a Kaplan-Meier curve. Cox proportional hazard model was used to calculate the hazard ratio (HR) and confidential interval (CI). During the median follow up of 3.0 years, 459 patients died. The cumulative 5-year mortality for the entire cohort was significantly lower in the PTXD than in the non-PTXD group (24.4% vs. 27.4%, respectively; HR, 0.81; 95% CI, 0.67–0.97; P=0.023), but this difference was no longer significant after adjustment for relevant covariates (HR, 1.01; 95% CI, 0.39–2.58; P=0.987). The Cox proportional hazard model revealed that sex, hyperlipidemia, Type 2 diabetes, hemodialysis, Rutherford category, and age above 75 years were significantly associated with 5-year mortality, but treatment with PTXD was not.Conclusions:This large individual meta-analysis of patients with femoropopliteal artery disease found that the use of PTXD does not have a negative effect on 5-year mortality.
To explore the associations between place of death and quality of death and dying and caregiver burden in terminally ill patients with cancer and their families.
Two bereavement surveys were ...conducted in October 2008 and October 2011. A total of 2,247 family caregivers of patients with cancer who were deceased responded to the mail surveys (response rate, 67%). Family members reported patient quality of death and dying and caregiver burden by using the Good Death Inventory and Caregiving Consequences Inventory.
Patient quality of death and dying was significantly higher at home relative to other places of dying after adjustment for patient and/or family characteristics (adjusted means): 5.0 (95% CI, 4.9 to 5.2) for home, 4.6 (95% CI, 4.5 to 4.7) for palliative care units, and 4.3 (95% CI, 4.2 to 4.4) for hospitals. For all combinations, pairwise P < .001; the size of the difference between home and hospital was moderate (Hedges' g, 0.45). Home was superior to palliative care units or hospitals with respect to "dying in a favorite place," "good relationships with medical staff," "good relationships with family," and "maintaining hope and pleasure" (P < .001 for all combinations of home v palliative care units and home v hospitals). Home death was significantly associated with a lower overall (P = .03) and financial caregiver burden (P = .004) relative to hospital death.
Dying at home may contribute to achieving good death in terminally ill patients with cancer without causing remarkably increased caregiver burden. Place of death should be regarded as an essential goal in end-of-life care.
Aim
To prospectively evaluate the efficacy and safety of stereotactic body radiotherapy (SBRT) for patients with previously untreated solitary primary hepatocellular carcinoma (HCC).
Methods
The main ...eligibility criteria included the following: (1) primary solitary HCC; (2) no prior treatment for HCC; (3) Child–Turcotte–Pugh score of seven or less; and (4) unsuitability for or refusal of surgery and radiofrequency ablation (RFA). The prescribed dose of SBRT was 40 Gy in five fractions. The primary endpoint was 3‐year overall survival (OS); the secondary endpoints included local progression‐free survival (LPFS), local control (LC), and adverse events. The accrual target was 60 patients, expecting a 3‐year OS of 70% with a 50% threshold.
Results
Between 2014 and 2018, 36 patients were enrolled; enrollment was closed early because of slow accrual. The median tumor size was 2.3 cm. The median follow‐up at the time of evaluation was 20.8 months. The 3‐year OS was 78% (95% confidence interval CI: 53%–90%). The 3‐year LPFS and LC proportion were 73% (95% CI: 48%–87%) and 90% (95% CI: 65%–97%), respectively. Grade 3 or higher SBRT‐related toxicities were observed in four patients (11%), and grade five toxicities were not observed.
Conclusions
This study showed acceptably low incidence of SBRT‐related toxicities. LC and OS after SBRT were comparable for previously untreated solitary HCC for patients unfit for resection and RFA. Although a definitive conclusion cannot be drawn by this study, the promising results indicate that SBRT may be an alternative option in the management of early HCC.
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BFBNIB, FZAB, GIS, IJS, IZUM, KILJ, NLZOH, NUK, OILJ, PILJ, PNG, SAZU, SBCE, SBMB, UL, UM, UPUK
Background. Community health workers (CHWs), often called “health promotion volunteers” in Japan, are individuals who act as a natural helping resource in the community. Aim. This study tested the ...efficacy of a CHW-based intervention to improve dietary habits among community-dwelling older people in Japan, using a controlled, crossover design. Method. Seventy-eight people aged 65 to 74 years with poor dietary variety living in four administrative districts in Hikone City (Shiga Prefecture, Japan) were nonrandomly allocated to an immediate-intervened group (IIG; n = 41) or a delayed-intervened group (DIG; n = 37). Participants joined a biweekly, four-session program (120 minutes/session), comprising “CHW drama-style lectures,” “group discussion among participants and CHWs,” “tasting of dishes,” and “take-home practical activities.” For the initial 2-month period, the IIG received the intervention and the DIG did not. The groups were crossed over for the subsequent 2-month period. The primary outcome measure was participants’ dietary variety score (score range: 0-10). Results. The dietary variety score in the IIG significantly increased in the initial 2-month period compared with the DIG (effect size 1.60 points; 95% confidence interval: 0.75, 2.45). The intervention had a similar effect in the DIG in the subsequent 2-month period. Moreover, an analysis within the IIG showed that the intervention effects persisted for at least 2 months after the intervention. Conclusions. The CHW-based intervention improved dietary habits among older people. Our findings provide evidence that a CHW-based natural helping approach is a possible solution to promote healthy aging in the community.
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BFBNIB, NMLJ, NUK, OILJ, PNG, SAZU, UKNU, UL, UM, UPUK, VSZLJ
Aim
Resilience, the ability to cope with disasters and significant life adversity, is an important factor to consider when studying the mental health of populations affected by a disaster. Although ...high school students in a community affected by a disaster should have specific characteristics of resilience, little has been reported on the issue. This study was designed to provide initial data regarding characteristics of the resilience of high school students affected by a catastrophe.
Methods
A total of 760 high school students in Natori City, which was devastated by the Great East Japan Earthquake in 2011, were profiled, and a 3‐year longitudinal study was conducted with 254 students who had entered the school in 2012. Resilience was evaluated with the 10‐item Connor–Davidson Resilience Scale. The Quick Inventory of Depressive Symptomatology–Japanese version, the Zung Self‐Rating Anxiety Scale, and the Impact of Event Scale–Revised were also administered to assess the students’ mental health.
Results
Among the students who entered the high school in 2012, 28.6% showed high resilience, and the proportion increased to 42.9% in 2013 and 46.6% in 2014. The Quick Inventory of Depressive Symptomatology–Japanese version and Impact of Event Scale–Revised scores decreased significantly over the 3‐year study period, but there were no significant differences in the Zung Self‐Rating Anxiety Scale scores over time.
Conclusion
This initial study profiling the characteristics of resilience among adolescents suggests that resilience is a highly changeable component of mental health among people who have faced adversity. Resilience can be a useful indicator of recovery from adversity and a target of interventions for improving mental health conditions.
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DOBA, FZAB, GIS, IJS, IZUM, KILJ, NLZOH, NUK, OILJ, PILJ, PNG, SAZU, SBCE, SBMB, UILJ, UKNU, UL, UM, UPUK
Fear of cancer recurrence (FCR) is a common distressing condition. We investigated the efficacy of smartphone problem-solving therapy and behavioral activation applications in breast cancer ...survivors.
This was a decentralized randomized trial. Participants were disease-free breast cancer survivors age 20-49 years who were randomly assigned to the smartphone-based intervention or waitlist control. Both groups received treatment as usual. The control group could access the smartphone apps during weeks 8-24. The intervention comprised smartphone problem-solving therapy and behavioral activation apps. The primary end point was the Concerns About Recurrence Scale at week 8. Secondary outcomes included the Fear of Cancer Recurrence Inventory-Short Form (FCRI-SF), the Hospital Anxiety and Depression Scale (HADS), the Short-form Supportive Care Needs Survey (SCNS-SF34), and the Posttraumatic Growth Inventory at weeks 8 and 24 (trial registration: UMIN-CTR: UMIN000031140).
The intervention group included 223 participants, and the control group included 224 participants. Primary outcome data were obtained for 444 participants, and 213 participants in the intervention arm completed the week 24 assessment. The intervention group had statistically greater improvements than controls at week 8 on the Concerns About Recurrence Scale (difference -1.39; 95% CI, -1.93 to -0.85;
< .001), FCRI-SF (difference -1.65; 95% CI, -2.41 to -0.89;
< .001), HADS depression (difference -0.49; 95% CI, -0.98 to 0;
< .05), and SCNS-SF34 psychological domain (difference -1.49; 95% CI, -2.67 to -0.32;
< .05). These scores at week 24 were not statistically significant compared with week 8 although the HADS depression score at week 24 was significantly reduced (
= .03).
Novel smartphone psychotherapy offers a promising way to reduce FCR given the large number of survivors and a limited number of therapists to competently conduct psychotherapy.
There are currently no methodological studies on the performance of the statistical models for estimating intervention effects based on the time-to-recurrent-event (TTRE) in stepped wedge cluster ...randomised trial (SWCRT) using an open cohort design. This study aims to address this by evaluating the performance of these statistical models using an open cohort design with the Monte Carlo simulation in various settings and their application using an actual example.
Using Monte Carlo simulations, we evaluated the performance of the existing extended Cox proportional hazard models, i.e., the Andersen-Gill (AG), Prentice-Williams-Peterson Total-Time (PWP-TT), and Prentice-Williams-Peterson Gap-time (PWP-GT) models, using the settings of several event generation models and true intervention effects, with and without stratification by clusters. Unidirectional switching in SWCRT was represented using time-dependent covariates.
Using Monte Carlo simulations with the various described settings, in situations where inter-individual variability do not exist, the PWP-GT model with stratification by clusters showed the best performance in most settings and reasonable performance in the others. The only situation in which the performance of the PWP-TT model with stratification by clusters was not inferior to that of the PWP-GT model with stratification by clusters was when there was a certain amount of follow-up period, and the timing of the trial entry was random within the trial period, including the follow-up period. In situations where inter-individual variability existed, the PWP-GT model consistently underperformed compared to the PWP-TT model. The AG model performed well only in a specific setting. By analysing actual examples, it was found that almost all the statistical models suggested that the risk of events during the intervention condition may be somewhat higher than in the control, although the difference was not statistically significant.
When estimating the TTRE-based intervention effects of SWCRT in various settings using an open cohort design, the PWP-GT model with stratification by clusters performed most reasonably in situations where inter-individual variability was not present. However, if inter-individual variability was present, the PWP-TT model with stratification by clusters performed best.
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DOBA, IZUM, KILJ, NUK, PILJ, PNG, SAZU, SIK, UILJ, UKNU, UL, UM, UPUK
Purpose
The aim of study was to explore the potential association between patient’s self-reported physical symptom management goals as personalized symptom goal (PSGs) and health-related quality of ...life (HRQOL) in cancer patients. The secondary outcome was to investigate the relationship between number of physical symptoms not achieving the PSGs and HRQOL in cancer patients.
Methods
This single-center prospective observational study comprised 140 consecutive outpatients. We evaluated the PSGs and HRQOL using the Functional Assessment of Cancer Therapy–General (FACT-G). Patients were administered a self-report questionnaire, including reports on their physical symptom intensity and PSGs using Edmonton Symptom Assessment System-revised (ESAS-r) scores. We investigated the correlation between PSGs achievement (ESAS-r score ≤ PSG score) and FACT-G total scores, and relationship between and number of physical symptoms not achieving the PSGs (ESAS-r score > PSG score) and FACT-G total scores.
Results
The patients who did not achieve PSGs of pain, tiredness, lack of appetite, and shortness of breath had a lower FACT-G total score (
p
< 0.05). Multivariate linear regression showed that higher number of physical symptoms not achieving the PSGs correlated with lower FACT-G scores (decreasing by 1.826 points for each such symptom,
p
< 0.01). Predictors of increased number of physical symptoms not achieving the PSGs were younger age and a higher symptom intensity of anxiety.
Conclusion
PSGs achievement was associated with HRQOL in cancer patients. Additionally, the number of unachieved PSGs were independent determinant of poor HRQOL, particularly in younger cancer patients and those with higher symptom intensity of anxiety.
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